Use of Salt-Water Solution to Improve Symptoms in Concussion

This study has been completed.

Sponsor:

Rady Children's Hospital, San Diego

ClinicalTrials.gov Identifier:

NCT00142090

First Posted: September 2, 2005

Last Update Posted: February 3, 2009

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The purpose of this study is to find out if 3% hypertonic saline (salt-water solution) given in a vein improves the headache that may be caused by a concussion. 3% hypertonic saline may also improve some of the other symptoms that may be caused by concussion (for example: confusion, nausea, vomiting).

This research is being done because there have been previous experience which suggests that 3% hypertonic saline has been beneficial in the treatment of children with more severe brain injury.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

6 Years to 17 Years (Child)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Greater than or equal to 6 years of age

Admitted for observation of closed head injury

GCS greater than or equal to 13

Presence of headache

CT scan showing no brain injury or only a small contusion (an area of low attenuation less than 10 mm or a punctuate area of high attenuation with surrounding edema less than 5mm). CT evidence of high or mixed attenuation would be consistent with a hemorrhagic lesion and therefore not qualify to participate in the study. Evidence of skull fractures and cephalohematomas on CT would not exclude the patient from the study.

Exclusion Criteria:

Age less than 6

GCS less than 13

Radiographic evidence of extra-axial blood or subarachnoid blood

Possible or witnessed posttraumatic seizure

Developmental delay/ mental retardation

Underlying cardiac or renal pathology

Suspected and/or documented use of alcohol and/or illicit substances

Medication history which includes administration of acetaminophen within 4 hours prior to enrollment or chronic anticoagulant use (ie: Coumadin, Aspirin

Associated injuries requiring the use of narcotics for analgesia (ie: long bone injuries, deep laceration repair)

Intubation

Non-English speaking

No parental consent

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00142090